UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001301 |
|---|---|
| Receipt number | R000001536 |
| Scientific Title | A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula,using viscera fat accumulation as a primary endpoint in adults patients with confirmed diagnosis of obesity and impaired glucose tolerance. |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2010/08/10 09:52:15 |
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Basic information
Public title
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
Acronym
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
Scientific Title
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
Scientific Title:Acronym
A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
Region
| Japan |
Condition
Condition
Obesity and impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare mitigation effect of Inslow
(palatinose-based liquid formula)and Meibalance(standard balanced liquid formula)on risk factors of metabolic syndrome in adults patients with obesity
and impaired glucose tolerance. The primary endpoint of efficacy for the study
is visceral fat accumulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat accumulation
Key secondary outcomes
Hemoglobin A1c
HOMA index
Area under the curb of glucose concentration after 75gOGTT
Area under the curb of insurin
concentration after 75gOGTT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Inslow(palatinose-based liquid formula)
ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
Interventions/Control_2
Meibalance(standard balanced liquid formula) ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Inclusion criteria at the preliminary
registration
1.BMI>=25Kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Volunteers with written informed consent
2)Inclusion criteria at the registration
1.BMI>=25kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Successful volunteers in the nutritional
period
Key exclusion criteria
1.Participants recieveing anti-diabetic
drug
2.Deep chronic drinker
3.Participants with following
complications or with past histry
*Exocrine diseases of pancreas:
Pancreatitis;Tumor;
Hemochromatosis,etc.
*Endocrine diseases:
Cushings's syndrome;Acromegaly,
Pheochromocytoma;
Hyperthyroidism,etc.
*Hepatic diseases:Chronic hepatitis,
Hepatic cirrhosis
*Patients with gastrectmy or with chronic
gastro-enteral disease
4.Female who is pregnant, in a lactation
period, child-bearing potential or
wishing to be pregnant.
5.Participants judged to be inadequate by
the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Takeda |
Organization
University of Tokushima Graduate School
Division name
Department of Clinical Nutrition
Zip code
Address
3-8-5Kuramoto-cho,Tokushima
TEL
088-633-7093
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Aonuma |
Organization
Meiji Dairies Corporation Food Science Institute
Division name
Nutrition Research Department Clinical Study and Scientific Assessment Section
Zip code
Address
540 Naruda, Odawara, Kanagawa
TEL
0465-37-3617
Homepage URL
HIROMITSU_AONUMA@MEIJI-MILK.COM
Sponsor or person
Institute
Meiji Dairies Corporation
Institute
Department
Personal name
Funding Source
Organization
Meiji Dairies Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Internal Medicine of Tokushima University
Hospital of Medicine and Dentistry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
1)長崎大学医学部・歯学部附属病院（長崎県） 1)Nagasaki University Hospital
2)徳島大学病院 2)Tokushima University Hospital
3)滋賀医科大学病院 3)Shiga Medical University Hospital
4)京都大学病院 4)kyoto University Hospital
5)松原ﾒｲﾌﾗﾜｰ病院 5)Matsubara Mayflower Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 06 | Day |
Last modified on
| 2010 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001536
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
